A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants

The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management protocols.

Evidence-based specific consensus guidelines for home regulated oxygen management do not currently exist. Current strategies for infants requiring outpatient supplemental home oxygen include brief checks of oxygen status during monthly clinic visits. Although the infants stay on monitors, no data in between visits is obtained to ensure that infants can maintain oxygen levels after weans are made. Before finally allowing oxygen to be removed, many centers also require an overnight sleep study in the hospital, to make sure that the infant's oxygen levels stay safe when the infant is in deep sleep. Because these methods rely solely on assumptions rather than individually recorded data, an infant's time on supplemental oxygen may be prolonged or insufficient. This study will evaluate both the currently used accepted therapy and a method of weaning that involves recording and sending oxygen data for analysis in between clinic visits.

Premature infants who require home oxygen therapy at time of discharge who meet eligibility criteria will be randomized into two arms:

Arm A ("Standard therapy"): Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits.

Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase, decrease or maintain oxygen between monthly visits.

Parents of all infants will be interviewed using structured quality-of-life questionnaires at the beginning and ending of the oxygen management process. Health care utilization (emergency department visits and rehospitalizations) and growth will be assessed 6 months after discontinuation of oxygen.

The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and eliminate need for polysomnogram, without compromising safety. The investigators will determine respiratory-related re-hospitalizations, emergency department (ED) visits, and growth parameters to confirm safety of the proposed weaning strategies.

Study Overview

• Status: Completed
• Conditions: Premature Infants
• Intervention / Treatment: Other: RHO

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Kentucky Children's Hospital at University of Kentucky
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Medical Center
  • New York
    • Valhalla, New York, United States, 10595
      • Boston Children's Hospital Physicians
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infant with birth gestational age ≤ 37 (37 0/7) wks postmenstrual age (PMA) who has requirement for supplemental O2 at time of NICU discharge, as determined by primary NICU team.
• Infant receiving pediatric pulmonology care at the Center for Healthy Infant Lung Development
• Parent aged 18 years or older
• English or Spanish-speaking.

Exclusion Criteria:

• Parents whose infants has presence of pulmonary hypertension at enrollment
• Parents whose infant with syndrome or other diagnosis with known high risk for persistent hypoxia (cardiac disease, Trisomy 21, Pierre-Robin Sequence, etc.)
• Parents whose infant has requirement for O2 flow rate > 1 L/min or tracheostomy
• Any infants who also require caffeine at discharge from the NICU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm A:Standard therapy; Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Polysomnograms will be utilized prior to final discontinuation of oxygen. RHO will only be utilized on the night prior to and during the polysomnogram to compare these two modalities.
Experimental: Arm B:RHO; Infants will have the same monthly clinic assessments as in Arm A, but also will utilize RHO to potentially increase, decrease or maintain oxygen between monthly visits. Parents will transmit a minimum of 4 days of stored RHO data (min 8 hrs per day) every 4-7 days. Changes in oxygen needs will be made based on standardized objective criteria. To determine discontinuation of oxygen, RHO will be utilized instead of polysomnography.	Other: RHO; Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Home Oxygen Therapy	Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).	NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months.
Caregiver Quality of Life	We will compare the difference between survey-derived quality-of-life scores, comparing parent response averages while on home oxygen therapy (HOT) versus 3 months post oxygen discontinuation scores in both arms. The infant scale is composed of 36 items comprising 5 dimensions. The item scaling is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores range from 0 to 100, with a higher score indicating a higher parent satisfaction and quality of life.	Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Respiratory-related Emergency Department Visits and Rehospitalizations	We will assess rates of rehospitalization or ED visit throughout the weaning process and continue to assess until 6 months post discontinuation.	WIthin 6 months of discontinuation of home oxygen
Growth Parameters	Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight z-score change was found in both arms for pre and post weaning from home oxygen therapy. The weight z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.	Enrollment to 6 months post home oxygen therapy discontinuation
Growth Parameters, Weight-for-length Z-score Change	Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight for length z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight for length z-score change was found in both arms for pre and post weaning from home oxygen therapy.The weight-for-length z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.	Enrollment through 6 months post discontinuation of home oxygen therapy

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Patient-Centered Outcomes Research Institute; Boston Children's Hospital; Dartmouth-Hitchcock Medical Center; Tufts Medical Center; University of Kentucky; University of Vermont Medical Center; UConn Health; Connecticut Children's Medical Center; Westchester Medical Center; Bay State Medical Center
• Investigators: Principal Investigator: Lawrence Rhein, MD, MPH, University of Massachusetts, Worcester; Study Director: Heather White, BS, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimated): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: NICU; supplemental oxygen; newborn intensive care unit
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: IP00009772